FDA.reportPublic FDA data

NDC 63629-8774-01 - SERTRALINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63629-8774
Requested NDC
63629-8774-01
Package NDCs from labels
63629-8774-1, 63629-8774-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SERTRALINE HYDROCHLORIDE - Bryant Ranch PrepackBryant Ranch Prepack2024-08-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8774-1SERTRALINE HYDROCHLORIDE1 in 1 CARTONSOLUTION1106
63629-8774-1SERTRALINE HYDROCHLORIDE60 mL in 1 BOTTLE, DROPPERSOLUTION60106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8774SERTRALINE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 2 package rows20240820_fa260c6c-9f6a-46a3-91ce-5665739d87e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8774-1ML - Milliliter63629-8774769a8c93-f42e-484d-9bab-1ae67dbe35b312022-01-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDELegacy Pharmaceutical Packaging, LLCbd86b293-dab9-4d37-95eb-2bffca335d162026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions5f0616f6-433f-45c9-86f4-f802fda5d8912026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEA-S Medication Solutionse46bc887-69e2-4037-be59-6513277d157b2026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEQuallent Pharmaceuticals Health LLC61835f25-bfe4-49ac-9dbf-3d6387866e782026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECipla USA Inc.cf71d1b9-5ebb-429f-a07f-a87cd168250f2026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HClSERTRALINE HYDROCHLORIDEBiocon Pharma Inc.623b9672-b41e-4ec9-b2cc-f5bb383c39ba2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEZydus Lifesciences Limited96dedceb-81ad-447c-800e-800cf473d4e42026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsfd92c8d3-17ec-477c-bc25-e5239c8606ac2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.0621fe8d-fdee-4d4c-a8e3-97f729472a582026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.48702ef4-21cd-754e-e063-6394a90af24e2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HClSERTRALINEAmneal Pharmaceuticals NY LLCa5c49e6e-b8e0-4a75-99e6-b88e323ce6532026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
SertralineSERTRALINEAvPAK10baaffd-061e-d665-e063-6294a90a15942026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECardinal Health 107, LLCfd8a815e-88b7-4bef-9e32-6dbc735711a32026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions7f62789b-61df-4b7b-9e01-c7a4dfb7e73c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions90524e6e-c34f-43eb-8c30-d99faf7ae08f2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthwind Health Company, LLCab0b0ef7-155b-cec9-e053-2a95a90a9fce2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.